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ZOLL Circulation, Inc. recalls Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central ve
Recalled October 13, 2021 · FDA recall Z-0054-2022 · ZOLL Circulation
Hazard
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing · FDA Class II
Units
2,833 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
Description
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Product
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
Manufacturer(s)
ZOLL Circulation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →